The Analysis of Factors Influencing the Vd of Imipenem in Septic Shock Patients

Sponsor

Southeast University, China (Other)

Overall Status

Completed

CT.gov ID

NCT03308214

Collaborator

(none)

Enrollment

Location

9.4

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study measures the plasma concentrations of imipenem in septic shock patients and non-septic shock patients and observes hypoalbuminemia and the impact of the severity of critical illness on Vd

Condition or Disease	Intervention/Treatment	Phase
Septic Shock	Drug: Imipenem

Detailed Description

Severe sepsis and septic shock are major causes of mortality in intensive care unit(ICU) patients.Correct and adequate antibiotic coverage is essential but can be complex as a result of fluid resuscitation, hypoalbuminemia, organ dysfunction, the application of extracorporeal support modalities and the impact of critical illness on pharmacokinetics(PK).Such changes will significantly distort the normal anti-biotic PK profile, resulting in drug exposure that is markedly different from the 'healthy volunteer.'The apparent volume of distribution is one of important PK parameters.Vd determines the loading dose. This review article considers these issues in detail, summarizing the key changes in antibiotic Vd in the critically ill, and providing general suggestions how to optimization of antibiotic dosing to manage Vd challenges.50 patients who receives the theapy of imipenem are included in this study.Whether hypoalbuminemia, organ dysfunction, the application of extracorporeal support modalities and the impact of critical illness on Vd will be evaluted.

Study Design

Study Type:

Observational

Actual Enrollment :

25 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

The Analysis of Factors Influencing the Apparent Volume of Distribution of Imipenem in Septic Shock Patients

Actual Study Start Date :

Mar 18, 2018

Actual Primary Completion Date :

Dec 28, 2018

Actual Study Completion Date :

Dec 28, 2018

Arms and Interventions

Arm	Intervention/Treatment
septic shock Patients with septic shock treat with Imipenem	Drug: Imipenem Imipenem 1.0 q 8h
non-septic shock Patients with infection but not septic shock treat with Imipenem	Drug: Imipenem Imipenem 1.0 q 8h

Arm

Intervention/Treatment

septic shock

Patients with septic shock treat with Imipenem

Drug: Imipenem

Imipenem 1.0 q 8h

non-septic shock

Patients with infection but not septic shock treat with Imipenem

Drug: Imipenem

Imipenem 1.0 q 8h

Outcome Measures

Primary Outcome Measures

the apparent volume of distribution [Day1, Day 3, Day 7]
The imipenem plasma concentrations are measured at different time to calculate Vd

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

age between 18 years old and 80 years old;
Admitted to the ICU;
Patients diagnosed as septic shock requiring the therapy of imipenem(0.5g q6h or 1.0g q8h;

Exclusion Criteria:

Patient participated in another interventional trial before enrollment
Allergy, hypersensitivity or a serious reaction to imipenem;
Pregnancy.
patients with ECMO and(or)CRRT.
tumors.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongda Hospital, Southeast University	Nanjing	Jiangsu	China	210009

Sponsors and Collaborators

Southeast University, China

Investigators

Principal Investigator: Songqiao Liu, PHD, Study Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Songqiao Liu, MD. PHD, Southeast University, China

ClinicalTrials.gov Identifier:

NCT03308214

Other Study ID Numbers:

2017ZDSYLL073-P01

First Posted:

Oct 12, 2017

Last Update Posted:

Jan 5, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Songqiao Liu, MD. PHD, Southeast University, China

septic shock; imipenem; VD ;pharmacokinetics

Additional relevant MeSH terms:

Shock, Septic

Shock

Imipenem

Study Results

No Results Posted as of Jan 5, 2021